When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have a real-world impact, and you’ll be supported in achieving your career goals.
Location/Division Specific Information
Pharmaceutical Services Group/Biologics – St. Louis, MO
How will you make an impact?
Manage departmental manufacturing resources to deliver meet and exceeds customer commitments and expectations. Ensures right the first time and on-time delivery of mammalian cell culture processes and protein purification processes to support clinical and commercial biologics manufacturing. Accountable of making sure demands are meet in accordance with established safety, quality, efficiency and regulatory standards.
Oversee all manufacturing resources including personnel and equipment.
What will you do?
- Manage day to day operations to ensure departmental commitments and deliverables are achieved to meet company objectives. This involves resource oversight, planning, delegation, prioritization, collaboration, etc. for Manufacturing groups.
- Maintain open communication via one-on-one and team meetings, and assure supervisory files are kept up to date.
- Encourage and oversee a culture of compliance regarding Safety, Environmental, Quality standards as required by cGMPs, Health Authority regulations, government agencies, and company standards / policies. Support all site audits and inspections.
- Ensure adequate manufacturing resources are dedicated to correcting important or critical issues
- Serve as a leader on departmental and site teams to improve and challenge processes, solve problems, initiate improvements, establish procedures, transfer new products or technologies, execute projects, etc.
- Responsible for working with the Senior Manager to mature area systems on an annual basis
- Conduct hiring, oversee training, prepare and communicate staff evaluations. Develop a team that is highly respected, engaged and actively develop and train high potential candidates for the next generation of leaders.
- Be a role model. Exude optimism. Support company direction and officers. Be a supporter and an asset to your peers. Be a representative for Manufacturing on site and back up / delegate for the backup for the area Senior Manager as required.
- Live the Thermo Fisher Scientific 4Is values every day. Be proactive.
- Select, develop and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures.
How will you get here?
Education
Bachelor’s degree required with a major in Biology, Biochemistry, Chemistry, Chemical Engineering, or related Science is preferable.
Experience
Five (5) to Seven (7) years of progressive experience within Biological or Pharmaceutical environment, preferred.
In addition to three (3) to seven (7) years of leadership/supervisory experience, strongly preferred.
Demonstrated success with continuous improvement and a dedication to craftsmanship and putting quality first.
Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities
- Understanding of production processes and the biopharma production environment.
- Knowledge in GMP’s and FDA regulations
- Knowledge of cGMP practices and quality system Understanding of cGMP quality systems (e.g. change control, deviations, investigations, risk assessments, driving GDP within all documentation and records
- Strong Mathematic, Mechanical Skills/ Analytical Skills/Method Automation
- Strong decision making skills.
- The ability to handle multiple ongoing activities and ability to prioritize tasks
- Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable
- Demonstrate ability to manage and lead professional staff in order to achieve goals and evaluate/resolve complex technical problems. Ability to motivate, energize and retain key staff by direct interactions with supervisors and staff. Lead by example; set the example for others to follow.
- Ability to work in a fast paced environment under pressure; able to multi-task and results-oriented.
- Highly effective verbal and technical writing/communication skills.
- Strong computer/ Quality and/or Financial software skills (i.e. Outlook, Excel, Word, PowerPoint,SAP, NextDocs, ComplianceWire, etc)
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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